Archive for the ‘Uncategorized’ Category

Clinically Integrated Networks – Fee Sharing Procedures

Tuesday, June 2nd, 2015

By John Fisher, JD, CHC, CCEP

Jointly Providing Health Care Fee Information to Payers 

As health care provider networks move down the path toward clinical integration, we are often asked to provide guidance on how information can be jointly provided to payors.  The antitrust laws recognize that collective sharing of some pricing information, even by otherwise competing providers, can be beneficial and does not necessarily violate antitrust laws.  However, there are significant limitations on what can be jointly provided and how the information can be shared.

At the outset, it should be clarified that collective negotiations by competing providers who are not financially or clinically integrated should never take place and constitutes a per se violation of federal antitrust laws.  Prohibited activities include any action in contemplation of or in furtherance of an agreement on fees or other aspects of reimbursement.  It is unlawful for a non-integrated group of competing providers to agree on or suggest a central fee schedule.  Any activity relating to prospective fees should be avoided.

Competing providers can jointly provide information on fees currently being charged or that have been charged in the past as long as certain safeguards are implemented and strictly followed.  The FTC and DOJ have stated that the joint provision

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Ambulatory Surgery Centers – Federal Settlement Highlights Safe Harbor Requirements

Tuesday, June 2nd, 2015

By John Fisher, JD, CHC, CCEP

ASC Investments Safe Harbors

A Tennessee based ambulatory surgery center company has agreed to pay damages to a former employee who filed a suit alleging that physician investments in local surgery center entities violated the Anti-kickback Statute.  The case highlights some of the unique kickback issues that are present in ambulatory surgery center structure.  Specifically, the case demonstrates how investment terms that are intended to assure compliance with the safe harbor regulations under the Medicare Anti‑Kickback Statute (42 U.S.C. § 1320a-7b(a)-(b)) can create evidence of non-compliance if the initial terms of the offering relate, in whole or in part, to the volume or value of expected referrals from the investor in the ASC venture.

In order to comply with safe harbor requirements, ASCs must generally require investing physicians to use the facility as an extension of their medical practices.  However, if the terms of the investment are based on the volume or value of referrals, those same requirements become evidence that referrals are being required in exchange for remuneration.  In the Tennessee case, the ASC management company purchased controlling interests in local surgery center entities at a high multiple of earnings.  Physicians who were referral sources were offered investments at less than 1/3 of the

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Primary Care Integration Strategies – The Division Model Group Practice

Tuesday, June 2nd, 2015

By John Fisher, JD, CHC, CCEP

 It is no secret that the role of primary care is central to the creation of systems to respond to health care reform and changing reimbursement models.  To the extent primary care providers have not already relinquished their strategic positions by becoming employed, entering provider service agreements or service line management agreements with hospital controlled systems, primary care providers maintain a strong position in the market.

Primary care groups are still faced with the need to create or participate in organizations that provide for the best means to manage patient care.  Primary care groups are seeking strength in numbers by creating larger groups.  The goal is to best maintain their competitive position, to diversify risk, to create efficiencies through shared savings opportunities, and to maintain appropriate levels of influence over care cycles, protocols and division of emerging, episodic-based payment.

In order to achieve these goals, some independent primary care groups are considering merger with other groups.  Oftentimes, merging providers will seek ways to maintain some degree of intra-office independence while still taking advantage of the benefit of a larger group.

Provider mergers and acquisitions, particularly between competing independent practices in the same specialty area, can create sensitive antitrust issues.  Generally, competing providers

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Some States Mandate Telemedicine Private Reimbursement

Wednesday, May 21st, 2014

By John Fisher, JD, CHC, CCEP

Private Reimbursement for Telemedicine – State Private Payment Mandates 

Failure of private reimbursement sources is one significant factor that impedes the development of telemedicine.  Some states have enacted laws that mandate some level of reimbursement for services provided by telemedicine.  The American Telemedicine Association has reported that 8 additional states have introduced telemedicine reimbursement laws already in 2013.  Those states include Florida, District of Columbia, Connecticut, Mississippi, Nebraska, Indiana, South Carolina, and New Mexico.  Some of the listed states have introduced general requirements that telehealth be reimbursed without discrimination.  Others have addressed more limited coverage .  Read more on this topic in the blog article that I posted on the Health Law Blog.

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Employment Exceptions From Anti-kickback Statute

Tuesday, May 20th, 2014

By John Fisher, JD, CHC, CCEP

employment exception safe harbor regulations

How Broad is the Employee Exception 

Parameters of the Stark Law and Anti-kickback Statute Exception

Both the Anti-Kickback Statute and the Stark Law contain exceptions that apply to employer/employee relationships.  Recent developments in the health law area indicate that there may be limits on the employment exception that were not previously contemplated.  I posted an article on the Health Law Blog that discussed possible limited to compensation structures for employed physicians.

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How Much Clinical Integration Is Enough?

Tuesday, May 20th, 2014

By John Fisher, JD, CHC, CCEP

Clinical Integration Attorney

 

Analysis of all available resources makes it clear that there is no single formula for achieving clinical integration and each organization will be unique in the mechanisms and processes that are used to achieve required levels of collaboration and interdependence between providers.  Clinical integration is a process of continual assessment and enhancement.  When we are speaking of clinical integration from an antitrust standpoint, we must determine whether the systems and mechanisms are in place and continuously operating to enhance quality and efficiency.

For more coverage of clinical integration, visit the clinical integration section of the Health Law Blog.

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Antitrust Law Application In Rural Areas- Hospital Mergers

Thursday, May 8th, 2014

By John Fisher, JD, CHC, CCEP

Antitrust Law Small Towns

Antitrust In Rural Areas

I just posted a blog article over at the Health Law Blog.  The blog article covers antitrust legal issues in rural healthcare settings.  One might tend to believe that the rather obscure area of antitrust law would have little application in small town America.  After all, most of the legal expertise on the antitrust is located in big cities (Ruder Ware being a major exception).

We are dealing with these antitrust issues on a more frequent basis as clinical integration resumes as a method of addressing health care reform.  These issues can be even more critical in rural areas where there might be only a handful of providers and limited competition.

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New Physician Assistant Supervision Requirements Effective March 1

Tuesday, March 11th, 2014

Wisconsin MEB Changes PA Supervision Requirements

The Wisconsin Medical Examining Board (MEB) recently approved several changes impacting physician supervision of physician assistants (PAs) in Wisconsin. These revisions are reflected in the Wisconsin Administrative Code Med 8 (Med 8) and became effective March 1, 2014. It is important that physicians be aware of the changes and the impact the revisions may have on their practice.

Here’s an overview of the key changes:

Supervising Physician to Ratio
A supervising physician may now simultaneously supervise four, rather than two, on-duty PAs. There is no limit to the number of PAs that a physician can supervise over time, and a PA may be supervised by more than one physician while on duty. A physician may still request authorization from the MEB to supervise additional PAs.

PA Prescribing
PA prescribing is simplified under Med 8. A PA may prescribe orders for drugs provided the PA’s prescriptive practices are initially reviewed, and at least annually reviewed after the initial review, by a supervising physician. Reviews must be documented and signed by the supervising physician, and the PA must be available to the MEB upon request.

Identifying the Supervising Physicians
Med 8 adds the requirement that the supervising physician must be readily identifiable by the PA. The rule does not require a specific manner of documentation—just that it is being documented.

Substitute Supervising Physicians
Substitute supervising physicians no longer need to be reported to the MEB.

On-Site Visit and Review of PA Practice Locations
A supervising physician is no longer required to make a monthly visit and on-site review of each facility where the PA practices.

The full text of Med 8 is available online. Physicians who supervise PAs should be conscious of the new requirements and adjust their practices accordingly to ensure compliance.

Increasing Opportunities in Home Health Care Industry

Thursday, January 30th, 2014

As Baby Boomers age and traditional institutional health care costs skyrocket, there is a trend toward providing care in lower cost settings.  Payment policies and patient demand are forcing more care into the patient’s home.  Much of the care that was historically provided in a residential post acute care setting is now being provided in a home setting.  As a result, the home health care industry is an emerging industry in Wisconsin and nationwide.

 What is home health care?

A home health agency is an organization that provides part-time and intermittent skilled nursing and other therapeutic and personal care services on a visiting basis to persons in their homes.  Generally, patients must be homebound to qualify for home health services under Medicare or their insurance company. 

By providing a wide range of services, home health care helps individuals live independently, given the limits of their medical condition.  Home health care is usually less expensive, more convenient, and just as effective as care that is provided in a more costly health care facility setting.  The level of home care service can be adjusted based on the patient’s needs.  Patients that require more intensive and ongoing care may receive “private duty” nursing care.  Patients that do not require skilled nursing may be provided lower level “personal care services” in their homes. 

 In Wisconsin, skilled nursing services provided in a patient’s home requires a licensed home health agency.  Less intensive personal care services may be performed by a home health agency or by a freestanding personal care provider that is approved by the state.  Personal care services are more limited and involve assistance with bathing, hygiene, change of bedding, and assistance with general life tasks.

Intermittent skilled nursing care provided by home health agencies include services that require a skilled nurse.  Examples include intravenous and intramuscular injections, foley catheter insertions, pain management, medication management, nursing assessment and other services that require the services of a licensed nurse.

One of the biggest barriers to starting a home health agency is the licensing/certification process.  Over the years, our law firm has worked with a number of home health providers to create the institutional structure necessary to obtain state licensure and Medicare certification.  Home health agencies must meet state licensing requirements and specific conditions of participation under Medicare.  The certification process involves creation of appropriate policies and procedures reflecting operational requirements.  Applicants must also go through a detailed survey by the Wisconsin Division of Quality Assurance and/or an independent survey by a private accreditation company. 

The Wisconsin Division of Quality Assurance also conducts ongoing unannounced surveys in home health agencies in Wisconsin to ensure that state licensure and federal Medicare certification requirements are met.  If the home health agency is out of compliance with rules, standards, or  regulations, the provider must correct the violation or face license and certification revocation and other penalties.  In extreme cases, licensure and certification can be suspended or revoked.

Home health care continues to be popular in the U.S., and the trend is likely to continue, given the increase in life expectancy and aging population.  We fully expect this aspect of our health law practice to continue to expand as this trend toward home health care continues.

Home Health and Hospice Compliance Focus

Monday, December 16th, 2013

By John Fisher, JD, CHC, CCEP

Home Health and Hospice in the Crosshairs

Governmental Enforcement Actions Against Post Acute Care Providers

Home health agencies and hospices are seeing a rapidly accelerating level of scrutiny by federal and state regulatory agencies.  Post acute providers need to take note of increased enforcement action and examine their level of readiness to undergo audit and review.  These organizations need to brush off their compliance and audit programs and take steps necessary to avoid the disruption and financial exposure that inevitably occurs when the government discovers a problem.

Compliance programs should create a systematic process to identify areas of risk that are specific to the type of provider and the specific nature of their operations.  A good place for providers to begin the risk identification process is to review OIG annual work plans, recent enforcement actions, newly enacted legislation and other external indications of areas of concern to regulators.

HHS officials have publicly stated that home health and hospices are areas of concern.  Sources of increased scrutiny include state survey agencies, CMS program integrity review organizations, the Office of Inspector General, Department of Justice and a variety of other agencies.  Regulators are widely using statistical analysis to identify potential outlier billings that may require further

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